Proof of Concept Study of a Sucker Hemostatic Intra Uterine in Postpartum Hemorrhage After Abruptio Placenta Assisted (HEMOGYN)
The postpartum hemorrhage (PPH) is the major complication of the delivery. In clinical practice, if after giving birth, the placenta is not expelled naturally, an active management should be triggered. Escalating therapy after obstetric maneuvers (placenta, uterus, examination of the birth canal), begins with uterotonic treatments for invasive treatments lead to embolization, vessel ligation and hysterectomy. However, the morbidity of these techniques and the desire to preserve fertility required to devise new therapeutic solutions, which have recently led to the development of an innovative medical device intrauterine hemostasis.
The postpartum haemorrhage are mainly the result of weak and bleeding from the surface corresponds to the placental insertion, which is no longer localized. With the innovative medical device, our main hypothesis is that the uterine walls will append to the walls of the cup after depressurization of the latter. The actuation of the suction cup will lead to aspiration of all sides of the uterus (it is mostly the anterior and posterior that are important). The suction cup is flexible to adapt to the size of the uterus in order to be placed and removed easily from the uterine cavity.
|No Placental Abruption No Hemorrhage||Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Vacuum Device for Hemostasis in Obstetrics and Gynecology: Proof of Concept Study in the Post Partum Hemorrhage|
- Number of participants for which there is a joining of the walls of the uterus around the suction cup after the depressurization. [ Time Frame: 18 month ]Comparison of ultrasound images before and after depression in the suction cup. The joining of tissues on the suction cup is characterized by a better visualization of posterior structures following the depressurization by eliminating air in the haemostatic intra-uterine suction cup.
- Number of participants for which the setting up of the suction cup in uterus is a successful. [ Time Frame: 18 month ]Qualification of success or failure of the setting up and score between 0 and 10 on a Visual,quantitative satisfaction scale.
- Number of participant for which there is a persistence of the joining walls of the uterus around the suction cup between 1 and 5 minutes at maximum after passage of the depression with Redon Drainobag®. [ Time Frame: 18 month ]
- Number of participants for which the withdrawal of the suction cup from the uterus is a successful. [ Time Frame: 18 month ]Qualification of success or failure of natural withdrawal of the suction cup and score between 0 and 10 on a visual, quantitative satisfaction scale.
|Study Start Date:||July 2012|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Suction cup Hemostatic Intra-Uterin
The suction haemostatic cup will be positioned into the uterus, and the aim is to stop haemorrhage
Device: Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)
The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01589744
|University Hospital Grenoble|
|Principal Investigator:||Véronique Equy, MD||Clinic of Gynecology and Obstetrics, University Hospital Grenoble - France|